FDA Commissioner Scott Gottlieb released new comments this week on the Agency's commitment to improving Expanded Access in the U.S. Add that to his recent memo recognizing the extraordinary potential of real-world evidence generated from pre-market clinical programs. Are you ready to use Expanded Access to engage more patients in your drug development plan?
Our all-star speaker faculty now includes Dr. Michael Kurilla, Director of the Division of Clinical Innovation at the NIH National Center for Advancing Translational Sciences (NCATS). With keynote speeches from Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, and Dr. Kate Goodrich, Director of the Center for Clinical Standards and Quality at CMS, this Health & Human Services trifecta will lead the largest public event ever to focus on pre-approval drug access. Be part of it, as we set the path for integrating modern, data-generating Expanded Access programs (EAPs) in the clinical development of new medicines worldwide.
The second annual Expanded Access Summit, Expanded Access 2.0, is the definitive national forum on pre-market access strategies and policy. This year we have an added global focus and a Day 2 module on bioethics and oversight.